One year later and still no judgment in urgent case about access to medicine

Judgment in a court case that affects the price of a blood-thinning medicine, rivaroxaban, has been outstanding for over a year.

• A judgment in an urgent matter about the sale of generic blood-thinning tablets has not been delivered, more than a year after the matter was heard.
• Pharmaceutical giant Bayer lodged an urgent application for an interdict to prohibit the sale of the tablet.
• Clicks opposed Bayer’s application. According to its court papers, the company was sitting with about 3,000 boxes of the generic.
• The generics are about 40% cheaper than Bayer’s pills.

June Bellamy’s 83-year-old mother got Covid in March 2022 and was in intensive care for two weeks. She was diagnosed with heart disease. When she was discharged, she was place on oxygen and prescribed medication, including blood-thinning tablets containing rivaroxaban.

During a visit to the doctor earlier this month, Bellamy and her mother were shown a list of different medications containing rivaroxaban. But when they tried to access the generic version at the dispensary, which is about 40% cheaper, the supervisor said that because of an ongoing court case they were not allowed to supply it anymore.

“We’ve had to buy the expensive one,” says Johannesburg resident Bellamy, who has been unemployed since 2017. It costs her R1,100 a month and she also has to buy other medications. She says her mother is on a basic medical aid region and the medication is not covered.

“While I’m financially decimated, I’m trying to enact what I can,” said Bellamy.

One year and counting

There are a number of court cases dealing with the issue. One of these is between Bayer and Clicks and was heard in the court of the commissioner of patents in Gauteng. The details are complicated and we define them below. But what is clear is that in April 2022 Judge Colleen Collis reserved judgment in this urgent matter about the sale of blood-thinning tablets. More than a year later, she has failed to hand down her ruling.

In urgent matters judgment is expected almost immediately. It is astonishing for a judge to hold a year over any judgment, let alone an urgent one. The judicial norms and standards state that judgments, in non-urgent matters, should be handed down within three months of being reserved.

GroundUp previously reported that the last available list of late judgments on the judiciary’s website is 31 December 2021. The judiciary has stonewalled our requests for an updated list.

We asked for comment from Chief Justice Raymond Zondo and Judge Collis but received no response.

What the case is about

The case deals with the extension of Bayer’s patent on rivaroxaban from December 2020 to January 2026.

In 2000, Bayer obtained a patent on rivaroxaban. Patents are granted for 20 years and so the patent was to expire in December 2020.

The patent-holder of a medicine, in this case Bayer, has exclusive control over it. No other pharmaceutical company may sell the medicine in South Africa during the patent period, at least not without Bayer’s permission. Effectively a patent holder has a monopoly. The point of patents is to create an incentive for pharmaceutical companies to develop current medicines.

In 2007 Bayer obtained a patent for rivaroxaban to be dosed once daily (the original patent was silent on dosing). This extended the patent to 19 January 2026. This kind of patent extension is widely criticised by health activists and is called evergreening.

After the initial patent expired in December 2020, two pharmaceutical companies, Austell and Dr Reddy’s, launched generic versions of rivaroxaban. To slice a long yarn short, there followed a series of court actions which resulted in Austell and Dr Reddy’s being interdicted from selling their versions of rivaroxaban in South Africa. But the interdicts did not yet cease the huge three pharmacy groups, Dis-Chem, Alpha Pharm and Clicks, selling the stock they had of both generic products.

Dis-Chem and Alpha Pharm reached a settlement with Bayer in respect of Dr Reddy’s product, Rivaxored, but Clicks did not. Bayer applied to the court of the commissioner of patents to interdict Clicks from selling rivaroxaban and obtained an urgent interim interdict in March 2022. Shortly after that, in April 2022, the main (and still urgent) hearing for this application took spot and Judge Collis reserved judgment. That is where matters stand, over a year later.

As of 13 May, OpenUp’s medicine price website gives the price of a pack of 42 Xarelto (Bayer’s rivaroxaban product) 15mg tablets as R1,532. Austell’s equivalent product, Rezalto, is R 931.26. Dr Reddy’s product, Rivaxored, is a diminutive higher priced than Rezalto (at 15mg) but considerably lower than Bayer. There’s also iXarola, Bayer’s “authorised generic”, which they brought to market honest before the expiry of the 2000 patent. It’s priced at R1,285. (These prices exclude the dispensing fee.)

The timeline below contains more detail.

Timeline

2000: Bayer gets patent for rivaroxaban (expires December 2020).

2007: Bayer gets patent for dosing rivaroxaban once daily instead of twice daily (effectively means that the patent expires on 19 January 2026).

2020, December: Initial patent expires.

2021, January: Austell launches its generic version of rivaroxaban, called Rezalto.

2021, April 1: Dr Reddy’s launches its generic version of rivaroxaban, called Rivaxored.

2021, May: Bayer obtains urgent interdicts that stay Austell from selling Rezalto.

2021, December: Bayer obtains interim interdict against Dr Reddy’s, but the interdict does not extend to stopping pharmacies from selling the stock they already had of Dr Reddy’s generic pills.

2022, January: Bayer then launches another urgent application to interdict three pharmacy groups from selling Dr Reddy’s generic pills still in stock. Dis-Chem and Alpha Pharm reach a settlement with Bayer. But Clicks refuses to settle and opposes Bayer’s application.

2022, March 15: Bayer obtains an urgent interim interdict against Clicks at the court of the commissioner of patents in Gauteng, pending a main hearing which takes plot at the same court in April.

2022, April: The urgent interdict application between Bayer and Clicks is heard by Judge Colleen Collis in the court of the commissioner of patents in Gauteng. Collis reserves judgment.

2023, May: Judgment has still not been handed down by Judge Collis.

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